A Phase 3 interventional study of Hypofractionated radiotherapy and Conventional arm in Pediatric Brain Stem Glioma, sponsored by Children's Cancer Hospital Egypt 57357. Completed at 1 site in Egypt. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-07-09.
Sponsored by Children's Cancer Hospital Egypt 57357 · Phase 3, Interventional, and Treatment
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.
In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.
This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 64 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Children's Cancer Hospital Egypt 57357 is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed
Radiation: Hypofractionated radiotherapy
The same planning and treatment procedures will be performed with the established conventional regimen: 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Radiation: Conventional arm
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Median overall-free survival
Time frame: 3 years
Progression-free survival
Time frame: 3 Years
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Children's Cancer Hospital Egypt 57357